BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTMAT SURGICAL ILLUMINATOR

    MDR report key: 2858093 · Received November 20, 2012

    Report

    Report Number
    MW5027939
    Event Type
    Other
    Date Received
    November 20, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    LUMITEXMD, INC.
    Product Code
    HJN
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT SUSTAINED A SECOND DEGREE BURN (1 CM X 0.5 CM) ON HER LEFT CHEST FROM THE LIGHTMAT SURGICAL ILLUMINATOR CONNECTOR. THE LIGHT SOURCE WAS USED DURING RIGHT AXILLARY SENTINEL NODE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTMAT SURGICAL ILLUMINATOR SURGICAL ILLUMINATOR HJN LUMITEXMD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other